NeurotoxicityNCT00263861
Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors
A study testing management of therapy complications in people with Neurotoxicity and Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably. PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of solid tumor
- Metastatic disease (stage IV)
- Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following:
- Taxane (paclitaxel or docetaxel)
- Platinum (cisplatin, carboplatin, or oxaliplatin)
- Diagnosis of type I or II diabetes mellitus
PATIENT CHARACTERISTICS:
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No other disease that reduces peripheral nerve function (e.g., HIV/AIDS, uremia, spinal injuries, alcoholism, or CNS problems)
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy
- No prior or concurrent neurotoxic drugs (i.e., vincristine)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5047
About this study
Official title: Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study
RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens.
- Determine the extent to which age, pre-existing diabetes mellitus, and level of glycemic control predict a differential pattern in outcome beyond the effect of the drugs in patients treated with these regimens.
- Develop a clinical assessment that would predict whether or not patients with diabetes mellitus are more or less susceptible to the neurotoxic effects of chemotherapy.
OUTLINE: This is a longitudinal study.
Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. Patients are evaluated at baseline, every 3 weeks during chemotherapy for up to 4 treatments, and at 2 months after completion of treatment.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Being tested
- management of therapy complications
- Keywords
- neurotoxicity, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous sensation as measured by Semmes-Weinstein monofilaments
Measured: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument
Measured: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Vibration as measured by tuning fork
Measured: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Lower extremity muscle strength as measured by Dynamometer
Measured: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Blood pressure changes
Measured: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Glycemic control as measured by Glycosylated Hemoglobin Assay
Measured: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurotoxicityStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Constance Visovsky, PhD, RN, ACNP, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263861
- Sponsor's protocol ID
- CWRU6Z03
- Other IDs
- P30CA043703, CASE-CWRU-6Z03
- Status last verified
- Jun 2010
- First submitted
- 7 Dec 2005
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study
- ClinicalTrials.gov ID
- NCT00263861
- Acronym / sponsor ID
- CWRU6Z03
- Keywords
- neurotoxicity, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 9 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens.
- Determine the extent to which age, pre-existing diabetes mellitus, and level of glycemic control predict a differential pattern in outcome beyond the effect of the drugs in patients treated with these regimens.
- Develop a clinical assessment that would predict whether or not patients with diabetes mellitus are more or less susceptible to the neurotoxic effects of chemotherapy.
OUTLINE: This is a longitudinal study.
Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. Patients are evaluated at baseline, every 3 weeks during chemotherapy for up to 4 treatments, and at 2 months after completion of treatment.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of therapy complicationsPatients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. | Procedure or surgery | – |
Primary outcome
Cutaneous sensation as measured by Semmes-Weinstein monofilaments
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Vibration as measured by tuning fork
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Lower extremity muscle strength as measured by Dynamometer
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Blood pressure changes
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Glycemic control as measured by Glycosylated Hemoglobin Assay
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
Related trials for Neurotoxicity
Not yet recruitingObservational study
RPM Signals in Outpatient CAR T Therapy
Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome
Recruiting
Assessing DCog Short for Neurotoxicity in CAR-T
Neurotoxicity, Neurotoxicity Syndromes
Active, not recruitingPhase 3
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Brain and Central Nervous System Tumors, Neurotoxicity
RecruitingPhase 4
Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
Immune Effector Cell Associated Neurotoxicity Syndrome
Active, not recruitingPhase 3
A Study to Compare the Long-term Outcomes After Two Different Anaesthetics
Anesthesia, Neurotoxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance Visovsky, PhD, RN, ACNP principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing management of therapy complications in people with Neurotoxicity and Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous sensation as measured by Semmes-Weinstein monofilaments (time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010; AzTrials last refreshed its copy on 6 Nov 2026.